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Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study

Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06024122
Acronym
KAOUENN
Enrollment
60
Registered
2023-09-06
Start date
2024-07-03
Completion date
2026-12-01
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI (Traumatic Brain Injury)

Brief summary

Concussions (also known as mild traumatic brain injury) are common in young children. In some children, they can lead to short- and long-term difficulties. However, our knowledge of the exact consequences of injuries on young children's brains and behavior is limited. These consequences may be different in children under 6, as their brains are fragile and undergoing significant developmental changes. The aim of this study is to determine the extent to which a concussion sustained before the age of 6 years is associated with changes in young children's brain structure, function and behaviours, using a brain imaging. In this study, the results of a group of 30 children with a concussion will be compared to those of 30 children of the same age with an orthopaedic injury to the upper or lower limbs.

Interventions

OTHERIRM exam

A non-sedated MRI scan will be performed to assess the structure and function of the children's brains

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV
Institut National de Recherche en Informatique et en Automatique
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
36 Months to 71 Months
Healthy volunteers
No

Inclusion criteria

* Patient group with mild traumatic brain injury (mTBI) : 1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) 2. Presentation to the emergency department within 48 hours post-injury 3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in non-penetrating head injury 4. Diagnosis of mTBI (World Health Organization (WHO) paediatric diagnostic criteria) * Control group with orthopaedic injury: 1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) 2. Presentation to the emergency department within 48 hours post-injury 3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in trauma to an upper or lower limb 4. Diagnosis of simple fracture, sprain, contusion or unspecified trauma to a limb (mild).

Exclusion criteria

* Diagnosis of previous TBI (any severity, any age) * Intentional injury, * Administration of sedative drugs that can alter brain function * Complications following injury * MRI contraindication, * Parent non-fluent in French, * Prematurity, * Diagnosis of a severe neurological, developmental, or psychiatric disorder * Children in foster care at the time of recruitment

Design outcomes

Primary

MeasureTime frameDescription
Persistent brain structure alterations3 months post-injuryQuantitative assessment of the brain morphometry extracted from T1-w MRI sequence

Secondary

MeasureTime frameDescription
Persistent brain lesions - Volume3 months post-injuryVolume of brain lesions measured with susceptibility MRI
Persistent brain lesions - Number3 months post-injuryNumber brain lesions measured with susceptibility MRI
Cerebral blood flow alteration3 months post-injuryCerebral blood flow quantified by arterial spin labelling perfusion MRI (ASL)
Functional integrity of brain networks3 months post-injuryFunctional connectivity (i.e., correlation between the activation of brain regions) measured by resting-state functional MRI
Structural integrity of brain networks3 months post-injuryWhite matter micro-structure measured by diffusion MRI

Countries

France

Contacts

CONTACTFanny DÉGEILH, PhD
fanny.degeilh@inserm.fr+33 2 99 84 71 63
CONTACTVéronique CHASLE, MD
veronique.chasle@chu-rennes.fr+33 2 99 26 67 58
STUDY_DIRECTORFanny DÉGEILH, PhD

Institut National de la Santé Et de la Recherche Médicale, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026